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目的 评价药代动力学软件(PKS)预测氨基糖苷类抗生素血浓度的准确性。方法 严重感染病人53例,静脉点滴氨基糖苷类抗生素q 6 h共3天。血药浓度测定用偏振荧光免疫测定法。用PKS软件Bayesian模式,以首次给药后峰和低浓度为反馈值,对以后每剂量的峰和谷浓度作预测。预测准确性和精确性用平均预测误差(ME)、均方预测误差(MSE)、均方预测误差平方根(RMSE)及其95％可信限表示。将24,48,72h峰、谷浓度实测值与预测值做配对t检验。结果 303次血药浓度实测值供预测。ME,MSE,RMSE及其95％可信限均在临床可接受范围内。24和48h峰浓度预测值和观察值间无显著差异(P>0.05),72 h组问差异有显著性(P<0.05)。上述3个时间点的谷浓度预测值和观察值间均有显著性差异(P<0.01)。结论 用PKS可准确预测氨基糖苷类静脉给药后4 8 h内每一剂量的峰浓度,但谷浓度预测受限。
Objective To evaluate the accuracy of pharmacokinetic software (PKS) in predicting blood concentrations of aminoglycoside antibiotics. Methods Severe infection in 53 patients, intravenous aminoglycoside antibiotics q 6 h for 3 days. Polarimetric fluorescence immunoassay for the determination of plasma concentration. Using Bayesian model of PKS software, the peak and trough concentrations of each dose were predicted after the peak and low concentration of the first administration as the feedback value. Prediction accuracy and accuracy are expressed as mean prediction error (ME), mean square prediction error (MSE), square root of mean square prediction error (RMSE) and its 95% confidence limit. The 24,48,72 h peak, trough the measured value and the predicted value of paired t test. Results 303 blood plasma concentrations for the prediction. ME, MSE, RMSE and their 95% confidence limits are within the clinically acceptable range. There was no significant difference between the predicted and observed peak values at 24 and 48 h (P> 0.05). There was a significant difference between the two groups at 72 h (P <0.05). There was a significant difference (P <0.01) between the predicted and observed values of trough concentrations at the above three time points. Conclusions PKS can accurately predict the peak concentration of each dose within 48 h after intravenous administration of aminoglycosides, but the prediction of trough concentration is limited.